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The 11 Must-Have Documents Of software Verification and Validation

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more


The verification and validation of medical industry software is coming under increased scrutiny by the U.S. FDA.

This webinar will address the use of the FDA, GAMP® , 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. If will focus on the 11 key software documents from an FDA Guidance Document.

The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if “risk-based”. How can this be done in the "real world". This webinar will address software that is:

1.As-Product;
2.In-Product;
3.Process and/or In Production and Test Equipment; and
4.The Quality System / CGMPs.

A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process.

Course Objectives:

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.

• A quick review of Internet forums will show much confusion about the subject.  Software is being developed for medical imaging, and even thought control of computers.  It is increasingly being used for e-records and e-signatures.

• The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing and validation phases, since replication of software is relatively defect-free.  Regulatory auditors are more comfortable with delving into software issues.

• Effective and real world software V&V is even more important in today’s resource constrained industrial environment.  This discussion will focus on a preferred U.S. FDA documentation "model" in various software/firmware applications, including ERP, in-device, as-device, process/equipment control, and cGMP data / 21 CFR Part 11 applications.

Course Outline:

• Verification or Validation -- FDA Expectations
• The Project Validation Plan
• An FDA-accepted Documentation "Model"
• Product and Process / Test / Facilities / Equipment Software V&V
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• The FDA’s 11 Key V&V Documentation Elements
• “White Box” and “Black Box” Validations
• GAMP® / Other Considerations

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Senior management in Drugs, Devices, Combination Products, Biologics, Dietary Supplements
• QA / RA
• Software development, programming, documentation, testing teams
• R&D
• Engineering
• Production
• Operations
• Consultants; others tasked with product, process, electronic records software V&V responsibilities

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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